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Prediction of Preeclampsia (PE) at 11-13 Week

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ClinicalTrials.gov Identifier: NCT03554681
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Chiu Yee Liona Poon, Chinese University of Hong Kong

Brief Summary:
This is an international multicentre prospective cohort study to validate the Bayes theorem based algorithms for the screening of pre-eclampsia (PE) in the first-trimester of pregnancy.

Condition or disease
Pre-Eclampsia

Detailed Description:

The investigators have previously constructed Bayes model in the first-trimester which combines maternal characteristics and medical history (Mat-CH) together with mean arterial pressure (MAP), uterine artery pulsatility index (PI), and serum placental growth factor (PlGF) with a plan to assess the predictive performance.

The reference standards will be PE defined according to the International Society for the Study of Hypertension in Pregnancy and the American College of Obstetricians and Gynecologists. The systolic blood pressure should be >140 mm Hg and/or the diastolic blood pressure should be >90 mmHg on at least two occasions four hours apart developing after 20 weeks' gestation in previously normotensive women and there should be proteinuria (>300 mg in 24 hours or two readings of at >2+ on dipstick analysis of midstream or catheter urine specimens if no 24-hour collection is available). In the absence of proteinuria, new onset of any of the following systemic findings: a) thrombocytopaenia (platelet counts <100,000 µL); b) renal insufficiency (creatinine >1.1 mg/dL or 2-fold increase in creatinine in the absence of underlying renal disease); c) abnormal liver function (ie, hepatic transaminase levels twice normal); d) pulmonary oedema; or e) cerebral or visual symptoms. Preterm-PE is PE that requires delivery before 37 weeks' gestation. If a participant fulfills the criteria for PE by one definition and not the other she will be considered to have developed PE.


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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Validation of Prediction Algorithms for Preeclampsia in the First-trimester of Pregnancy
Actual Study Start Date : December 2016
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The false positive and true positive frequencies for screening for PE using the Bayes theorem based methods [ Time Frame: At delivery ]

Secondary Outcome Measures :
  1. The false positive and true positive frequencies for screening of delivery of all-Small for Gestational Age (SGA) neonates and preterm-SGA neonates (delivery before 37 weeks), with or without PE [ Time Frame: At delivery ]

Biospecimen Retention:   Samples Without DNA
An additional blood 5ml sample, if agreed to by the study participant, for recovery of plasma for future research will be taken and archived at -80℃.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All eligible women attending for their hospital visit at 11-13 weeks will be invited to participate.
Criteria

Inclusion Criteria:

  • Aged ≥ 18 years
  • Singleton pregnancy
  • Live fetus
  • Provide Informed and written consent in the official language of the country

Exclusion Criteria:

  • Unable to provide written Informed consent learning difficulties or serious mental illness or an inability to understand spoken and written the official language of the country.
  • Multiple Pregnancy
  • Non-viable fetus (missed spontaneous abortion or stillbirth)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554681


Contacts
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Contact: Prof Poon (852) 3505 2582 liona.poon@cuhk.edu.hk

Locations
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China
First Affiliated Hospital of Kunming Medical University Recruiting
Kunming, China
Contact: Run Mei Ma, MD         
Nanjing Drum Tower Hospital Recruiting
Nanjing, China
Contact: Ya Li Hu, MD         
Hong Kong
Kwong Wah Hospital Recruiting
Hong Kong, Hong Kong
Contact: Wing Cheong Leung, MD         
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Liona Poon, MD         
India
Mediscan Chennai Recruiting
Chennai, Tamil Nadu, India
Contact: SESHADRI Suresh, MD         
Japan
Toyama University Hospital Recruiting
Toyama, Toyama Prefecture, Japan
Contact: Shigeru Saito, MD, PhD         
Clinical Research Institute of Fetal Medicine PMC Recruiting
Osaka, Japan
Contact: Ritsuko K Pooh, MD, PhD         
Affiliated hospitals within The Japan Society for the Study of Hypertension in Pregnancy (JSSHP) Recruiting
Tokyo, Japan
Contact: Shigeru Saito         
Showa University Hospital Recruiting
Tokyo, Japan
Contact: Akihiko Sekizawa, MD, PhD         
Singapore
KK Women's and Children's Hospital Recruiting
Singapore, Singapore
Contact: George SH Yeo, MD         
National University Hospital Recruiting
Singapore, Singapore
Contact: Mahesh A Choolani, MD, PhD         
Taiwan
Taipei Chang Gung Memorial Hospital Recruiting
Taipei, Taiwan
Contact: Steven SW Shaw, MD, PhD         
Thailand
Chulalongkorn University Bangkok Recruiting
Bangkok, Thailand
Contact: Boonchai Uerpairojkit, MD         
Siriraj Hospital Recruiting
Bangkok, Thailand
Contact: Tuangsit Wataganara, MD         
Sponsors and Collaborators
Chiu Yee Liona Poon
Investigators
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Principal Investigator: Liona CY Poon Chinese University of Hong Kong

Publications:

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Responsible Party: Chiu Yee Liona Poon, Associate Professor (Clinical), Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03554681     History of Changes
Other Study ID Numbers: 2016.152
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chiu Yee Liona Poon, Chinese University of Hong Kong:
Bayes Model

Additional relevant MeSH terms:
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Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications